The Biotechnology Industry Organization (BIO) is a trade association representing over 1,100 companies, academic institutions, and biotechnology centers. BIO members are involved in the research and development of biotechnological healthcare, agricultural, environmental and industrial products. In the healthcare sector alone, the biotechnology industry has more than 370 therapeutic products currently in clinical trials being studied to treat more than 200 diseases. The vast majority of BIO members are small companies that have yet to bring a product to market and attain profitability.
BIO has a great interest in this case because its members must rely heavily on the patent system to protect their platform technologies, their commercial embodiments, and to grow their businesses in the decades to come. Enforceable patents that cannot be easily circumvented, and that can be predictably enforced against infringers, enable biotechnology companies to secure the financial support needed to advance biotechnology products through regulatory approval to the marketplace, and to engage in the partnering and technology transfer that is necessary to translate basic life science discoveries into real-world solutions for disease, pollution, and hunger. Proprietary biotechnological processes, and method patents that protect them, often count among a biotechnology company’s most valuable business assets. The steps of such processes can often be practiced by different entities. Consequently, patent claims to such processes are often capable of being practiced separately, and BIO members have a strong interest in clear, ascertainable rules of infringement liability that discourage parties from circumventing infringement liability by dividing up their otherwise infringing activities. Accordingly, BIO submits this brief to assist this Court’s longstanding efforts to guide the evolution of patent law in a tempered, predictable way that will accommodate new emerging technologies to the benefit of all and guard against unforeseen consequences that might cripple reasonably-based business expectations in the life sciences.